Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

Hepatitis C Clinical Trial

Official title:

A Prospective Observational Post-Marketing Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562742
• Other study ID #: GS-US-334-1879
• Status: Completed
• Phase: N/A
• First received: September 28, 2015
• Last updated: July 28, 2017
• Start date: November 12, 2015
• Est. completion date: June 12, 2017

Study information

• Verified date: July 2017
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: June 12, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis

• Patients who are prescribed SOF+REB

Key Exclusion Criteria:

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Infection
• Virus Diseases

Intervention

Drug:
• SOF
SOF 400 mg tablets administered orally once daily
• REB
REB capsules administered orally in a divided daily weight-based dose according to the package insert for the approved Rebetol® labeling in Japan (< 60 kg = 600 mg , > 60 kg to = 80 kg = 800 mg, and > 80 kg = 1000 mg)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gilead Sciences	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reaction (ADR) under real world settings		Up to 16 weeks
Secondary	Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)	SVR12 and SVR24 are defined as HCV RNA < the lower limit of quantification (LLOQ) 12 and 24 weeks following the last dose of study drug, respectively.	Posttreatment Weeks 12 and 24
Secondary	Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks		Approximately 12 weeks after treatment completion or discontinuation